Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years

23. august 2013 opdateret af: Wales Cancer Trials Unit

A Pilot Clinical Trial Looking at the Effect on Lung Cancer Diagnosis of Giving a CXR to Smokers Aged Over 60 With Chest Symptoms

RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer treatment. It is not yet known whether standard medical care is more effective than an urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.

PURPOSE: This randomized clinical trial is studying standard medical care to see how well it works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To determine the prevalence of extra-NICE symptoms in patients consulting in UK general practice.
  • To determine the proportion of patients who agree to participate in the trial.
  • To determine the proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers.

Secondary

  • To determine the best way to train general practitioners to identify and recruit eligible patients into the trial.
  • To determine the most effective method of presenting the trial (and randomization) to patients.
  • To determine the barriers to recruitment and how to overcome those barriers.
  • To determine the best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays.
  • To determine the best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'.
  • To determine the stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm A: Patients are managed as per the National Institute for Health and Clinical Excellence (NICE) guidelines.
  • Arm B: Patients are referred for an urgent chest x-ray according to extra-NICE guidelines.

General practitioners from South East Wales are surveyed to assess their level of interest in the proposed full trial. For the feasibility study, 20 South East Wales general practices and 6 South Yorkshire general practices are selected. General practitioners are trained to recruit all patients who fulfill the extra-NICE criteria as well as those who do not.

Patients complete questionnaires (HADS, EQ-5D, and ICECAP[O]) at baseline and at 2 months to measure quality of life and health economic analysis of the cost-effectiveness of extra-NICE guidelines.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

386

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Patients over 60 seeing a participating General Practitioner

  • Currently smokes 10 or more pack years, meeting at least one of the following criteria:

    • New or altered cough of any duration reported to primary care
    • Increased breathlessness or wheezing (with or without purulent sputum)

  • Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following:

    • Cough
    • Chest/shoulder pain
    • Dyspnea
    • Weight loss
    • Chest signs
    • Hoarseness
    • Finger clubbing
    • Features suggestive of metastasis from a lung cancer (e.g., in the brain, bone, liver, or skin)
    • Cervical/supraclavicular lymphadenopathy

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No chest x-ray within in past 3 months
  • No need for a chest x-ray within the next 3 weeks for reasons other than those listed under Disease Characteristics

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Prevalence of extra-NICE symptoms in patients consulting in UK general practice
Proportion of patients who agree to participate in the trial
Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers

Sekundære resultatmål

Resultatmål
Best way to train general practitioners to identify and recruit eligible patients into the trial
Most effective method of presenting the trial (and randomization) to patients
Barriers to recruitment and how to overcome those barriers
Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays
Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'
Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer
False-positive and false-negative rates for chest x-rays

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wales Cancer Trials Unit

Efterforskere

  • Ledende efterforsker: Richard Neal, MD, North Wales Clinical School

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2011

Primær færdiggørelse (Forventet)

1. juni 2013

Datoer for studieregistrering

Først indsendt

27. april 2011

Først indsendt, der opfyldte QC-kriterier

27. april 2011

Først opslået (Skøn)

28. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2013

Sidst verificeret

1. april 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000699222
  • WCTU-EL-CID
  • EU-21112
  • CRUK-C8350/A12199

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med spørgeskemaadministration

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Suriname

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner